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Clotrimazole Topical Solution USP, 1% 10 mg/mL Solution — NDC 71399-0666-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clotrimazole Topical Solution USP, 1% 10 mg/mL Solution — NDC 71399-0666-3 (Billing 71399-0666-03)

by Akron Pharma Inc. · 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE

This is a package of Clotrimazole Topical Solution USP, 1% 10 mg/mL Solution from Akron Pharma Inc., marketed since Oct 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 71399-0666-03
🏷️ FDA NDC (as labeled) 71399-0666-3 billing pads the package segment with a zero
This package
Contains30 mL in 1 bottle Pack sizes2 compare ↓
Also priced by: Part D plans $0.6637/unit — full pricing hub ↓
Main listing for product 71399-0666 · Also comes in: 2 bottles 71399-0666-6
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 71399-0666-3 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71399 labeler · 0666 product · 3 package
Package marketed since
May 4, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7139906663 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71399-0666-3
Product NDC 71399-0666
11-digit billing NDC 71399066603
NCPDP billing unit ML — per mL (volume)
RxCUI 309370
UNII G07GZ97H65
Application # ANDA216569
SPL Set ID 32b968ce-e112-441c-a91f-c62f2f67b57c
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-16
Route TOPICAL
Dosage form SOLUTION
Substance CLOTRIMAZOLE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90154020002005
GCN Seq No 007362
GCN 30380
HICL code 004137
Ingredient (HICL) Clotrimazole
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name CLOTRIMAZOLE 1% SOLUTION
FDB brand name Clotrimazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007362
  • GCN: 30380
  • GPI-14 (Medi-Span): 90154020002005
  • HICL (First Databank): 004137
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 309370
Why two NDCs? The FDA registers this code as 71399-0666-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71399-0666-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Imidazole and triazole derivatives, Imidazole derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CLOTRIMAZOLE 1% SOLUTION Ingredient Clotrimazole
📖 What it is MedlinePlus · NLM

Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats fungal and yeast infections. Skin products treat athlete's foot, jock itch and ringworm. Vaginal creams treat vaginal yeast infections, and CLOTIC ear solution treats fun...
  • Wash and dry the area, then apply a thin layer twice a day, morning and night. Most labels say about 4 weeks for athlete's foot and ringworm and 2 weeks for jock itch. See a doctor...
  • The skin products listed here say they are not effective on the scalp or nails. If the infection is there, check with your doctor.
  • With CLOTIC ear solution, the reported ones were headache, pain where it goes in, ringing in the ear and tingling. Vaginal cream can briefly increase burning or itching. Call your...
📖 Read our full Clotrimazole guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.6637 $19.91 / 30 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71399-0666-03 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2024-05-04 — Active
71399-0666-06 71399-0666-6 2 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE 2024-03-25 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 30 ml in 1 bottle.
What NDC number is used to bill for this package of Clotrimazole Topical Solution USP, 1% 10 mg/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clotrimazole 10 mg/mL 51672-1260-03 Sun 1 bottle $0.426 AT Availability likely —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 52817-0800-30 TruPharma 1 bottle $0.426 AT Availability likely —
Clotrimazole 10 mg/mL 70954-0036-20 Novitium 1 bottle $0.426 AT Availability likely —
Clotrimazole 1 g/100mL 00536-1443-70 Rugby 1 bottle $2.018 — Availability likely —
Clotrimazole 1 g/mL 51672-2158-01 Sun 1 bottle $2.018 — Availability likely —
Clotrimazole 1 g/mL 70010-0229-54 Granules 10 ml $2.018 — Availability likely —
Clotrimazole (Topical Solution), 1% 10 mg/mL 83474-0003-34 Puro 1 bottle $2.018 — Availability likely —
Clotrimazole 1 g/mL 00536-1181-70 RUGBY 10 ml $2.371 — FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 50228-0502-08 ScieGen 1 bottle $2.742 AT Availability likely —
Clotrimazole 1 g/mL 10135-0671-81 Marlex 1 bottle — — FDA listed —
Clotrimazole 1 g/mL 50268-0044-30 AvPAK 1 bottle — — FDA listed —
Fungicure Intensive 10 mg/mL 52389-0600-60 Kobayashi 1 bottle — — FDA listed —
Fortinia OF 1 g/100mL 54633-0017-01 The 29.57 ml — — FDA listed —
Clotrimazole 1 g/mL 54633-0018-10 The 1 bottle — — FDA listed —
Fortinia Ultra 1 g/100mL 54633-0025-15 The 15 ml — — FDA listed —
Fortinia 1 g/100mL 54633-0214-01 The 29.57 ml — — FDA listed —
Lasolex Liquid Solution 10 mg/mL 59088-0251-03 PureTek 30 ml — — FDA listed —
Clotrimazole 1 g/mL 68788-4080-01 Preferred 10 ml — — FDA listed —
Clotrimazole Antifungal 10 g/L 69396-0143-33 Trifecta 1 bottle — — FDA listed —
Akin Anti-Fungal 10 mg/mL 69822-0254-05 Southern 1 bottle — — FDA listed —
Smooth Gator Fungus Eliminator 10 mg/mL 70673-0747-01 Smooth 59 ml — — FDA listed —
Clotrimazole 1 g/mL 70795-8020-01 GRAXCELL 10 ml — — FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 71297-0030-02 Allegis 2 bottles — AT FDA listed —
Clotrimazole 1 g/mL 71399-0500-01 Akron 10 ml — — FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mLthis 71399-0666-03 Akron 1 bottle — AT FDA listed —
Clotrimazole Topical Solution USP, 1% 10 mg/mL 72162-2178-03 Bryant 1 bottle — AT FDA listed —
WELMATE Clotrimazole Topical Solution 10 mg/mL 73581-0449-00 YYBA 1 bottle — — FDA listed —
Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution 10 mg/mL 83004-0042-01 Rida 3 bottles — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 7V31YC746X
    Chloroform is a clear liquid solvent historically used in pharmaceutical formulations to dissolve or extract active ingredients and other substances. It may appear in some older medicines or specialized preparations as a solvent or preservative component.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAkron Pharma Inc.
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA216569 (ANDA)
Labeler code71399
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio44 products on file

More NDCs from Akron Pharma Inc. labeler code 71399

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 70 words ▾

INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .

⏱️ Dosage and Administration 69 words ▾

DOSAGE AND ADMINISTRATION Gently massage sufficient Clotrimazole Topical Solution, USP 1% into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with Clotrimazole Topical Solution, USP 1%. If the patient shows no clinical improvement after 4 weeks of treatment with Clotrimazole Topical Solution, USP 1% the diagnosis should be reviewed.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

⚠️ Warnings 9 words ▾

WARNINGS Clotrimazole Topical Solution is not for ophthalmic use.

🤒 Adverse Reactions 48 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritius, urticaria, burning, and general irritation of the skin. To report SUSPECTED ADVERSE REACTIONS, contact Akron Pharma, Inc. at 1-877-225-6999 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 23 words ▾

Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

🤰 Pregnancy 199 words ▾

Usage in Pregnancy The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans. (See CLINICAL PHARMACOLOGY ) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects.

There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole. High oral doses of clotrimazole in rats and mice ranging from 50 mg/kg to 120 mg/kg resulted in embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning.

However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200 mg/kg, 180 mg/kg and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.

🧒 Pediatric Use 22 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have been established for clotrimazole when used as indicated and in the recommended dosage.

🆘 Overdosage 21 words ▾

OVERDOSAGE Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur . The primary action of clotrimazole is against dividing and growing organisms. In vitro , clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida species including Candida albicans .

In general, the in vitro activity of clotrimazole corresponds to that of tolnaftate and griseofulvin against the mycelia of dermatophytes ( Trichophyton, Microsporum, and Epidermophyton), and to that of the polyenes (amphotericin B and nystatin) against budding fungi ( Candida ). Using an in vivo (mouse) and an in vitro (mouse kidney homogenate) testing system, clotrimazole and miconazole were equally effective in preventing the growth of the pseudomycelia and mycelia of Candida albicans . Strains of fungi having a natural resistance to clotrimazole are rare.

Only a single isolate of Candida guilliermondi has been reported to have primary resistance to clotrimazole. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans and Trichophyton mentagrophytes . No appreciable change in sensitivity was detected after successive passages of isolates of C. albicans, C. krusei, or C. pseudotropicalis in liquid or solid media containing clotrimazole.

Also, resistance could not be developed in chemically induced mutant strains of polyene-resistant isolates of C. albicans . Slight, reversible resistance was noted in three isolates of C. albicans tested by one investigator. There is a single report that records the clinical emergence of a C. albicans strain with considerable resistance to flucytosine and miconazole, and with cross-resistance to clotrimazole; the strain remained sensitive to nystatin and amphotericin B.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively after addition of the drug. Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites.

Following topical and vaginal administration, however, clotrimazole appears to be minimally absorbed. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm 3 , in the stratum corneum to 0.5 mcg/cm 3 to 1 mcg/cm 3 in the stratum reticulare, and 0.1 mcg/cm 3 in the subcutis. No measurable amount of radioactivity (≤ 0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream.

Only 0.5% or less of the applied radioactivity was excreted in the urine. Following intravaginal administration of 100 mg 14 C-clotrimazole vaginal tablets to nine adult females, an average peak serum level, corresponding to only 0.03 mcg equivalents/mL of clotrimazole, was reached 1 to 2 days after application. After intravaginal administration of 5 g of 1% 14 C-clotrimazole vaginal cream containing 50 mg active drug, to five subjects (one with candidal colpitis), serum levels corresponding to approximately 0.01 mcg equivalents/mL were reached between 8 and 24 hours after application.

📦 How Supplied / Storage and Handling 45 words ▾

HOW SUPPLIED Clotrimazole Topical Solution, USP 1% is supplied as follows: NDC 71399-0666-3 in 30 mL round bottle in carton NDC 71399-0666-6 in 2 x 30 mL round bottles in a carton Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📦 Storage and Handling 13 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 87 words ▾

DESCRIPTION Clotrimazole Topical Solution USP, 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following structural formula: Molecular Formula C 22 H 17 ClN 2 Molecular Weight 344.85 Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol, and chloroform. Each mL of Clotrimazole Topical Solution, USP 1% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400.

Chemical Structure

💬 Information for Patients 93 words ▾

Information for Patient This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. The patient should be advised to: Use the medication for the full treatment time even though the symptoms may have improved.

Notify the physician if there is no improvement after 4 weeks of treatment. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. Avoid sources of infection or reinfection.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General If irritation or sensitivity develops with the use of clotrimazole, treatment should be discontinued and appropriate therapy instituted. Information for Patient This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

The patient should be advised to: Use the medication for the full treatment time even though the symptoms may have improved. Notify the physician if there is no improvement after 4 weeks of treatment. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.

Avoid sources of infection or reinfection. Laboratory Tests If there is lack of response to clotrimazole, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy. Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

Carcinogenesis, Mutagenesis, and Impairment of Fertility An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect. In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight.

The results of this study showed that clotrimazole had no mutagenic effect. Usage in Pregnancy The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans.

(See CLINICAL PHARMACOLOGY ) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole.

High oral doses of clotrimazole in rats and mice ranging from 50 mg/kg to 120 mg/kg resulted in embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning. However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200 mg/kg, 180 mg/kg and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose.

Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients have been established for clotrimazole when used as indicated and in the recommended dosage.

🍼 Nursing Mothers 34 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 74 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect. In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight.

The results of this study showed that clotrimazole had no mutagenic effect.

📄 Package Label / Principal Display Panel 3 words ▾

carton carton 2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Akron Pharma Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 2 bottles (71399-0666-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Akron Pharma Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71399-0500-01 · Akron 71399-1014-01 · Akron →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.